MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CANNULATED 5.5 POLYSCREW 4.5X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	3505-4545
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that during the final tightening of a set screw, the torque wrench clicking sound was sluggish and the set screw was damaged.The set screw was replaced, however the second and third set screws were damaged in the same way.The bone screw was also damaged, and removed and replaced with a new screw, and the final tightening of the set screw was successful.This caused a 15 minute delay to the procedure, however there was no patient impact.This is report four of five for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tulip has disassembled from the screw shank.Additionally, the threads on the tulip have damage.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excessive forces applied during use or cross threading of the closure top.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference reports 3012447612-2024-00370 through 3012447612-2024-00372 and 3012447612-2025-00022.
Event or Problem Description
It was reported that during the final tightening of a set screw, the torque wrench clicking sound was sluggish and the set screw was damaged.The set screw was replaced, however the second and third set screws were damaged in the same way.The bone screw was also damaged, and removed and replaced with a new screw, and the final tightening of the set screw was successful.This caused a 15 minute delay to the procedure, however there was no patient impact.This is report four of five for this event.

• Brand Name: CANNULATED 5.5 POLYSCREW 4.5X45
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 21163594
• Report Number: 3012447612-2025-00021
• Device Sequence Number: 9320829
• Product Code: NKB
• UDI-Device Identifier: 00889024335592
• UDI-Public: (01)00889024335592(10)81LW
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132884
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3505-4545
• Device Lot Number: 81LW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic